The Role of Oseltamivir During Influenza Outbreaks in Aged-care Facilities in the Context of Optimal Influenza Vaccination and Infection Control
Do Residential Aged Care Facilities benefit from oseltamivir treatment of cases plus prophylaxis of contacts, versus oseltamivir treatment of cases alone, with respect to reducing influenza outbreak frequency, duration and complications?
Children's Hospital, Westmead: National Centre for Immunisation Research and Surveillance
74 participants
Jun 1, 2016
Interventional
Conditions
Summary
This protocol proposes a cluster-randomised study of 70-100 aged-care facilities with partnership between various stakeholders: aged care facilities, clinical researchers, general practitioners, government public health bodies, and relevant industry partners. It has two main purposes: (i) to examine the impact of oseltamivir, as treatment only, versus treatment and prophylaxis, for residents and staff of ACFs during influenza outbreaks with respect to morbidity, mortality and outbreak size, and (ii) to develop and test an enhanced surveillance system, utilising bedside rapid point-of-care tests with laboratory confirmation, for respiratory infection outbreaks in ACFs; both in the context of promoting influenza vaccine uptake and infection control measures.
Eligibility
Inclusion Criteria1
- Any participating residential aged care facility (ACF) from whom written consent has been obtained is eligible to receive the randomly assigned intervention.
Exclusion Criteria3
- Subjects who have a known hypersensitivity to oseltamivir or any of its components (see Appendix)
- ACFs who withhold consent
- Residents or staff who have had symptoms suggestive of influenza for longer than 72 hours, as from then there is no *Staff who are pregnant or currently breastfeeding.
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Interventions
Oseltamivir treatment course in influenza cases in staff or residents plus oseltamivir prophylaxis of contacts Treatment regimen of oseltamivir: 75mg orally twice a day with a meal/snack for five days in those diagnosed within 48 hours of influenza symptoms by rapid bedside or laboratory testing Prophylaxis regimen: 75mg orally daily of oseltamivir for ten days or until outbreak is declared over, whichever is longer, with snack/meal Medicines will be charted on a medication chart and signed off as administered by staff within the aged care facility which documents compliance Electronic surveillance systems implemented in aged care facilities for early identification of an influenza outbreak: defined as 3 or more epidemiologically linked cases of influenza-like illness in residents or staff of the facility within a period of 72 hours PLUS at least one case having a positive laboratory test OR at least two having a positive point of care test“. The Australian Aged Care Standards and Accreditation agency require ACFs to incorporate infection surveillance within their infection control programmes. There are currently no systematic surveillance systems for infectious diseases across ACFs in Australia, although most have some internal surveillance is carried out. Improved surveillance of can enable earlier outbreak identification and control. This study will implement electronic surveillance systems and observe their uptake, benefits and drawbacks. Rapid point-of-care tests (POCT) for influenza are used once to diagnose those with influenza-like symptoms - Nose and throat swabs will be collected from each consenting resident and staff member during screening by ACF staff using flocked swabs for rapid point of care testing (SOFIA / QUICKVUE (Registered Trademark) Influenza A+B Test; Quidel Corp., San Diego, CA., USA or BinaxNOW (Registered Trademark) Influenza A&B; Alere Inc., Florida, USA). Where feasible, a second nasal swab from a sample of patients affected by the outbreak will be collected for nucleic acid testing for influenza virus DNA, both POCT positive and POCT negative but symptomatic; study staff may assist with this. These will be transported to the laboratory at 4 degrees C in viral transport medium
Locations(1)
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ACTRN12615000638538